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Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy

NCT02422498•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically-confirmed invasive triple negative breast cancer (ER \<1%, PR \<1%, her-2-neu 0-1+ by IHC or FISH-negative) or as determined by MD discretion
•Radiation to the recurrent or metastatic site is clinically indicated and would be considered standard care for palliation or for locoregional control
•Age ≥18 years
•Tumor to be irradiated is measurable by RECIST 1.1 or PRC
•Willingness to undergo tumor biopsy prior to initiation of treatment
•Life expectancy greater than 6 months
•ECOG performance status 0-2
•Any prior chemotherapy is allowed including prior treatment with platinum-containing chemotherapy
•Prior treatment with FDA-approved or investigational biologics or novel molecularly target therapies, including oral or IV formulations, are permitted.
•Patients must be off prior targeted therapy for at least 14 days prior to study biopsy.
+8 more criteria

Exclusion Criteria

•Unmeasurable target tumor site by RECIST 1.1 or PRC (ex: lesions \<2 cm on CT or MR scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis, non-FDG-avid skin lesions)
•Brain metastases requiring focal or whole brain radiation will be excluded, as these lesions cannot be biopsied and can have life expectancies \<6 months.
•Inability to obtain a biopsy of the tumor as deemed by the study Interventional Radiologist
•Prior chemotherapy completed \<7 days prior to planned study entry
•Prior RT is allowed and must have been completed more than 7 days before planned study entry.
•* Note: For re-irradiation cases, standard departmental guidelines should be followed so as to not exceed normal tissue
•Life expectancy less than 6 months
•Intercurrent illness or other major medical condition or comorbid condition that might affect study participation (uncontrolled renal, pulmonary or hepatic dysfunction or infection)
•Renal dysfunction for which cisplatin dose would be considered unsafe.
•Women on study must be neither pregnant nor nursing nor expected to become pregnant during therapy. For premenopausal women, negative pregnancy test within 14 days of RT is required.
+1 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

April 14, 2015

Primary Completion Date

December 19, 2022

Completion Date

December 19, 2022

Last Updated

February 9, 2024

Enrollment

ACTUAL participants

Conditions

Locally Recurrent/Metastatic Triple Negative Breast Cancer

Interventions

external beam radiation therapy

RADIATION

cisplatin

DRUG

Biopsy of Target Tumor

PROCEDURE